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GMP Awareness for Excipients Manufacturers
Delivered at your site

GMP Awareness for Excipients Manufacturers

Updated Tuesday, 14 April 2026 at 18:01

Comprehensive 1-day GMP Awareness training for excipient manufacturers focused on ExciPact guideline compliance and quality system fundamentals.

One trainer, one team, your site

Run for your team at your location. We adapt the material to your products, SOPs and recent inspection findings — taught by the same trainers who run our public PCS Academy courses.

Request a custom training quotation

What's included

  • Programme adapted to your products and SOPs
  • Trainer travels to your site — no staff time lost
  • Dates that fit your production schedule
  • Individual certificate for every participant
  • Same trainers who teach our public PCS Academy courses

Difficulty

Beginner level

Topics

GMP EudraLex Volume IV Quality Assurance Calibration Validation Qualification Manufacturing Excipients

Categories

Good Manufacturing Practice (GMP) | GMP Training

Also available as in-house

What you will learn

Understand what GMP means and why it is essential for pharmaceutical excipient suppliers

Recognize the importance and value of ExciPact guidelines in harmonizing global GMP expectations

Understand how quality is defined and managed through quality systems in excipient manufacturing

Apply basic quality system elements (Change Control, CAPA, Risk Management) to operational scenarios

Understand ALCOA+ principles and their application to documentation and data integrity

Identify deviations and understand the CAPA process for continuous improvement

Recognize personal responsibility and the importance of quality culture in GMP compliance

Understand how ExciPact compliance impacts day-to-day activities and supplier-customer relationships

Description

This GMP Awareness training is specifically designed for excipient manufacturers and emphasizes the ExciPact guideline framework. ExciPact is the collaborative guideline developed by industry associations to harmonize GMP expectations for pharmaceutical excipient suppliers globally.

Key Focus Areas:

  • GMP principles specific to excipient manufacturing
  • ExciPact guideline requirements and expectations
  • Quality system elements critical for excipient suppliers: Change Control, CAPA, Risk Management
  • Documentation and Data Integrity (ALCOA+ principles)
  • Supplier responsibilities and customer requirements
  • Deviation management and continuous improvement
  • Role of quality culture in excipient manufacturing

The training balances theoretical knowledge with practical application, enabling participants to understand how GMP and ExciPact requirements translate to daily operations in excipient manufacturing facilities.

Target Audience

Excipient manufacturers, quality assurance staff, production personnel, and supervisors responsible for GMP compliance. Essential for organizations supplying pharmaceutical excipients to regulated customers and aiming to demonstrate GMP competence under ExciPact standards.

Contents

This training covers GMP fundamentals with emphasis on ExciPact guideline requirements for excipient suppliers. Participants learn quality system elements, documentation practices, data integrity, deviation management, and supplier responsibilities.

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Programme

Results

Participants will understand practical GMP implications for excipient production, recognize the importance of quality systems under ExciPact, and understand how GMP requirements impact daily activities in excipient manufacturing.

Request a custom training quotation

Tell us a bit about your team — head count, the topics you need covered, your preferred dates and your site location. We will come back with a tailored proposal and price, usually within one working day.